Drugs / Cytogam
Cytogam
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | CYTOGAM | idiopathic disseminated cytomegalovirus infection | 2023-01-04 | “today announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) to manufacture CYTOGAM®” kamada.com ↗ “Submitted applications to the U.S. Food and Drug Administration (FDA) and to Health Canada to manufacture CYTOGAM®” kamada.com ↗ |
| Filed | Other | CYTOGAM | idiopathic disseminated cytomegalovirus infection | — | “Submitted applications to the U.S. Food and Drug Administration (FDA) and to Health Canada to manufacture CYTOGAM®” kamada.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07096453 | Oct 2025 → Aug 2027 expected | cytomegalovirus infection | University of Minnesota | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT04934527 | Nov 2021 → Dec 2024 | cytomegalovirus infection | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT00881517 | Jun 2009 → Oct 2011 | cytomegalovirus infection | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | Missed primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT06958796 | Nov 2025 → Dec 2027 expected | cytomegalovirus infection, disease related to solid organ transplantation | Camille N. Kotton, MD | Recruiting | No outcome recorded |
| Phase 4 | NCT07009548 | Jun 2025 → Dec 2027 expected | cytomegalovirus infection | Fernanda P Silveira, MD, MS | Enrolling by invitation | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT00275509 Background | Jan 2007 → Jun 2010 | chronic renal failure syndrome | Johns Hopkins University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-07-13 | Kamada, Ltd. | Results Kamada Highlights CYTOGAM® Study Results Presented at the 2026 ISHLT Annual Meeting kamada.com ↗
In a retrospective analysis of clinical data, researchers found that among CMV high-risk lung transplant recipients, patients who did not receive CMVIG prophylaxis experienced worse clinical outcomes compared with those who received CMVIG prophylaxis and other CMV serotype groups. |
| 2023-10-16 | Kamada, Ltd. | Results Kamada Announces Recent Achievements with CYTOGAM® including Availability of Product Manufactured by the Company for U.S Commercial Sale and Presentation of New Clinical Data kamada.com ↗
New Clinical Data Highlighting Five-year Real-world Survival Benefits of High Risk CMV Mismatch Lung Transplant Patients Receiving CYTOGAM were Presented at IDWeek 2023 |
| 2023-05-24 | Kamada, Ltd. | Regulatory Kamada Reports Strong First Quarter 2023 Financial Results; Reiterates Revenue and Profitability Guidance kamada.com ↗
Received FDA Approval to Manufacture CYTOGAM® at the Company’s Israeli Facility; Expected t o Positively Impact Plant Utilization and Efficiency |
| 2023-05-03 | Kamada, Ltd. | Regulatory Kamada Announces U.S. FDA Approval of its Application to Manufacture CYTOGAM® at the Company’s Facility in Israel kamada.com ↗
The FDA approval represents the successful conclusion of the technology transfer process for CYTOGAM from the previous manufacturer, CSL Behring. |
| 2023-01-04 | Kamada, Ltd. | Regulatory Kamada Announces Submission of Application to the U.S. FDA to Manufacture CYTOGAM® at the Company’s Facility in Israel kamada.com ↗
The application was submitted as a prior approval supplement (PAS) and FDA approval is currently expected by mid-2023. |
All press releases naming this drug 7 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CytoGam | “CytoGam - Cytomegalovirus Immune Globulin Intravenous (CMV-IGIV), is an immunoglobulin G containing a standardized amount of antibody against CMV.” NCT07009548 ↗ |
| Known as | CMVIg | “100 mg/kg of Cytogam (CMVIg) (Cytogam, CSL Behring, King of Prussia, PA) was administered” NCT00275509 ↗ |
| Known as | Cytomegalovirus Immune Globulin Intravenous (Human) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06958796 ↗ |
| Known as | Cytotect | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00881517 ↗ |
| Action | Activate | “The anti-CMV IgGs capturing virions thus activate CD16+ LTgdVd2neg with production of IFN interferon which in turn is responsible for inhibition of CMV viral multiplication.” NCT04934527 ↗ |
| Modality | Protein / enzyme biologic | “intravenous immunoglobulin infusion” NCT00275509 ↗ |
| Route | Intravenous | “receive Cytotect® or placebo intravenously” NCT00881517 ↗ |